Search Results

The Ponto Bone Anchored Hearing System (Ponto sound processors and implant system) is intended for the following patients and indications:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 4 sound processors, 55 dB HL for use with the Ponto 3 Power sound processors and 65 dB HL for use with the Ponto 3 SuperPower sound processor.

· Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies.

· Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/ abutment system (refer to the Ponto labeling for compatible BAHA sound processor models).

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the user by the snap coupling. The technological characteristics of the Ponto Bone Anchored Hearing System, Ponto Implant System, remain unchanged from the original design (most recently cleared in K152067).

The Ponto Bone Anchored Hearing System also include accessories and instruments for installation of the implantable components, and the Ponto Surgical Manual and Surgical Manual Addenda include step by step instructions for a number of safe alternative surgical approaches for implant installation.

The main purpose of this 510(k) notification is a modification to the drilling to prepare the osteotomy for installation of a Ponto bone anchored implant, from two-step drilling (MIPS previously cleared in K152067) to a single drill step (MONO). The MONO Surgery Kit is a further development of the MIPS Surgery Kit previously cleared in K152067.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Oticon Medical AB's Ponto Bone Anchored Hearing System, specifically the MONO Surgery Kit. This document focuses on demonstrating substantial equivalence to a predicate device (K152067), rather than providing detailed acceptance criteria and the comprehensive study results typical of a novel device or a device making significant new claims.

Therefore, many of the requested details about acceptance criteria, test set sizes, expert involvement, and ground truth establishment are not explicitly stated in this type of regulatory submission, as the primary goal is to show that the modified device (MONO Surgery Kit) is as safe and effective as the previously cleared predicate. The "study" here is a set of pre-clinical bench tests demonstrating equivalence rather than a clinical trial validating performance against specific acceptance criteria for diagnostic accuracy.

However, I can extract information related to the device modifications, the comparative testing performed, and the conclusions drawn for substantial equivalence.

Here's a breakdown of the available information:

Key Takeaway: This 510(k) submission is for a modification to an existing device (a new surgical drilling technique and associated kit - MONO Surgery Kit) and aims to prove substantial equivalence to a predicate device (K152067). It is not a submission for a novel device requiring extensive clinical validation against specific performance metrics for diagnostic accuracy. Therefore, information typically found in such studies (like MRMC, detailed ground truth establishment, or large-scale clinical trials) is largely absent or not relevant in this context.

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic AI device. Instead, it describes comparative bench testing against a predicate device to demonstrate equivalence.

The implicit acceptance criteria are that the new "MONO" drill performs comparably to the "MIPS" predicate drill across key metrics, confirming "equivalence" in safety and efficiency.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document mentions "Comparative testing to install 4 mm Ponto implant (Ø4.5 mm) in artificial bone." It does not specify the number of tests or samples conducted.
• Data Provenance: The tests were "Pre-clinical bench tests." The location of these tests or the origin of the "artificial bone" is not specified. It is a laboratory, not a clinical, test.
• Retrospective or Prospective: Not applicable as these are bench tests, not patient studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable and not provided in the document. The "ground truth" for these bench tests would be directly measured physical properties (heat, torque, etc.) in artificial bone, not expert consensus on medical images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable as the study involved bench testing of a physical device/technique, not human interpretation or adjudication of data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was NOT done. This type of study (MRMC) is typically performed for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is evaluated. The device subject to this 510(k) is a surgical kit for a hearing system, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable to this device. The device is a surgical kit, not an algorithm. The "performance" evaluated was the physical interaction and outcomes of the drill in artificial bone.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the pre-clinical bench tests was based on direct measurements of physical properties (heat generation, insertion torque, installation turns, seating, ISQ-value) in artificial bone. The performance was then compared against the established performance of the predicate device.

8. The sample size for the training set

• This document describes a 510(k) for a medical device (surgical kit), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

• As there is no AI/Machine Learning algorithm or training set involved, this question is not applicable.

Ask a specific question about this device